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The Effect of Creatine Supplementation Associated With Resistance Training on Sarcopenia Parameters and Muscle Density in Prostate Cancer Patients After Androgen Deprivation Therapy

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This randomized, double-blind, placebo-controlled clinical trial will investigate the effects of creatine supplementation combined with a 12-week supervised resistance training program on muscle mass, muscle strength, physical performance (e.g., parameters of sarcopenia), and muscle density in men with prostate cancer undergoing androgen deprivation therapy (ADT). ADT often causes loss of lean mass, reduced muscle strength, functional impairment, and increased fat mass. Eligible male patients will be randomly assigned to receive either creatine monohydrate or a placebo (maltodextrin) in a double-blind manner, in addition to participating in the resistance exercise program. Assessments will be performed at baseline and after the 12-week intervention period and will include: * Muscle density and architecture assessed by ultrasound * Body composition (lean mass and fat mass) * Muscle strength * Physical performance (functional performance tests) * Inflammatory biomarkers * Vascular function parameters The primary goal is to assess whether creatine supplementation combined with resistance training can safely improve muscle quality and quantity, strength, and physical function in these patients. If effective and safe, the intervention could help reduce muscle loss and improve quality of life in men undergoing ADT.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 40
Healthy Volunteers: f
View:

• Men aged ≥ 40 years;

• Patients with histologically or cytologically confirmed localized prostate cancer;

• Patients who have undergone surgical castration or pharmacological castration with gonadotropin-releasing hormone (GnRH/LHRH) agonists or antagonists for at least six months prior to the start of the intervention;

• Patients receiving continuous or intermittent androgen deprivation therapy;

• Patients with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;

• Not engaged in resistance training in the three months prior to the intervention;

• Not using creatine supplementation in the three months prior to the intervention;

• Willing to participate in a 12-week intervention consisting of resistance training performed three times per week and daily supplementation with creatine monohydrate or maltodextrin.

Locations
Other Locations
Brazil
School of Physical Education and Sport - USP
RECRUITING
São Paulo
Contact Information
Primary
Guilherme WP da Fonseca, PhD
guilhermefonseca@usp.br
+55 11 3091 2137
Backup
Comitê de Ética em Pesquisa da EEFE-USP
cep39@usp.br
+55 11 3091 3097
Time Frame
Start Date: 2026-05-01
Estimated Completion Date: 2029-01
Participants
Target number of participants: 34
Treatments
Experimental: Creatine Supplementation + Resistance Training
Participants assigned to the experimental arm will complete a 12-week supervised, progressive resistance training program and receive 5 g/day of creatine monohydrate. Creatine supplementation will be administered daily throughout the intervention period.
Active_comparator: Placebo (Maltodextrin) + Resistance Training
Participants assigned to the control arm will complete a 12-week supervised, progressive resistance training program and receive 5 g/day of maltodextrin. Maltodextrin will be administered daily throughout the intervention period.
Related Therapeutic Areas
Sponsors
Leads: University of Sao Paulo
Collaborators: Instituto do Cancer do Estado de São Paulo, InCor Heart Institute, Medical school of the University of São Paulo (FMUSP)

This content was sourced from clinicaltrials.gov